Lyophilization

With 60 years of experience in the engineering and manufacturing of freeze dryers, GEA has delivered more than 1000 installations and conducted thousands of freeze drying tests for the pharmaceutical and biotechnology industries, underlining the company’s technological leadership and unparalleled expertise.

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Pharmaceutical Freeze Drying

From its earliest applications in the stabilization of blood plasma in the 1940s, freeze drying has become a standard practice in the life science industries. Since that time, the freeze dryer — or lyophilizer — has evolved from a simple device for low temperature vacuum drying to an extremely sophisticated and integrated system that combines a number of processes to ensure that a product is consistently delivered to exacting technical and biological specifications, while complying with a number of economic, safety and environmental issues.

As a fill and finish process, freeze drying plays a key role in aseptic pharmaceutical and biotech production. Lyophilized products retain their original properties and, by adding water or a suitable solvent, they can be easily and quickly reconstituted. As such, freeze drying is widely used as a preservation method. Each product requires specific process parameters to be identified and optimized, including the initial freezing process, which is of great importance for the final product structure. The shelf temperature and the corresponding sublimation pressure during primary drying determine not only the drying time but also the quality of the final product.

Typical quality aspects are original property retention, cake appearance, reconstitution time and shelf-life. The freezing and melting behaviour of the product is tested in the laboratory to establish the correct outcome from the start. These test results then form the parameters for further pilot testing to develop the freeze drying process, reduce time-to-market and ensure effective scale-up to full production.

GEA was one of the first freeze drying companies to deliver Automatic Loading and Unloading Systems (ALUS™) for freeze dryers and integrate isolators and CIP-skids into a complete freeze dryer/ALUS™ system. Our range of supplies and services comprises pilot-scale freeze dryers for R&D purposes and small production batches; industrial-size freeze dryers; and complete freeze dryer systems including Automatic Loading and Unloading Systems (ALUS™). In addition, the company can service and retrofit existing freeze dryers.

All design and manufacture is done in accordance with cGMP, CE, GAMP5 and 21 CFR Part 11 guidelines. And, with expertise in freeze drying and related processes such as isolator technology, sterilisation and clean-in-place (CIP), we can help you to process all kinds of pharmaceuticals and biotechnology derived products, including hormones, vaccines, antibiotics anti-infectives, bacteria, sera, enzymes, diagnostic agents, monoclonal antibodies (mAbs) and blood products.

For more than half a century, GEA has designed and manufactured freeze dryers for the pharmaceutical and biotech industries. During this time, the company has remained dedicated to the development and optimisation of lyophilization technology and contributed substantially to both design and process control.